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The goal of this clinical trial is to learn if acupuncture can play a role in reducing pain and improving the quality of life of post-radiotherapy nasopharyngeal cancer mucositis patients. The main questions it aims to answer are:
- Do manual acupuncture and medication therapy affect pain intensity as measured by the visual analogue scale (VAS) in patients with oral mucositis compared with sham manual acupuncture and medication?
Participants will receive acupuncture therapy 2 times a week for 3 weeks
This is a clinical trial study to evaluate the role of acupuncture in pain relief and improving the quality of life of nasopharyngeal cancer patients with post-radiotherapy mucositis. Participants were 30 men/females with mucositis in post-radiotherapy nasopharyngeal cancer aged 19-59 years. They will be divided into 2 groups: (1) verum acupuncture and (2) sham acupuncture. Acupuncture is scheduled 2 times per week for 3 weeks. Research assessment on pain scale and improvement in quality of life
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum Acupuncture | Experimental | The verum acupuncture group will receive actual acupuncture therapy 2 times per week for 3 weeks |
|
| Sham Acupuncture | Sham Comparator | The Sham acupuncture group will receive Sham acupuncture therapy 2 times per week for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum Acupuncture | Procedure | Acupuncture therapy uses filiform needles at a perpendicular angle at acupuncture points to produce a therapeutic effect. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | VAS is used to assess pain complaints on a scale of 1-10. The VAS scale consists of: mild pain scale 1-3, moderate pain scale 4-6 and severe pain scale 7-10 | Monitored 2 times per week for 3 weeks, and followed up again at week 4 without intervention. |
| European Organization For Research And Treatment Of Cancer Head and Neck Cancer Quality of Life Questionnaire (EORTC QLQ-H&N35) | The EORTC QLQ-H&N35 is a questionnaire designed to assess the health-related quality of life in patients with head and neck cancer. It consists of 35 questions covering various aspects such as pain, swallowing, speech, social eating, and emotional functioning. Each question is scored on a scale from 1 to 4, with 1 representing "not at all" and 4 representing "very much". To calculate a score for each domain, the individual item scores are averaged. Higher scores indicate more severe symptoms or poorer quality of life in that domain. Additionally, there are specific guidelines provided by the European Organization for Research and Treatment of Cancer (EORTC) for scoring and interpreting the results, with a minimum and maximum scale of 0-33: mild, 34-66: moderate, 67-100: severe. | Monitored before and after intervention. After the intervention; Results will be measured at week 3 after intervention and results will be measured at week 4 without intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imelda Dimara, MD | Contact | +6282319769944 | imeldadimara560@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| KEPK FKUI-RSCM | The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM | Principal Investigator |
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| Sham Acupuncture | Procedure | Sham Acupuncture therapy uses filiform needles but is only attached with tape to acupuncture points |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000077274 | Nasopharyngeal Carcinoma |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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